FDA-Device2017-05-24Class I

Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065CE WGM35090US WGM35090CE WGM35135US WGM35135CE

ReFlow Medical
Hazard

ReFlow Medical is recalling the Wingman 35 Crossing Catheter because it may be prone to tip detachment.

Sold states
Worldwide Distribution - US Nationwide in the states of : NJ, FL, CA, GA, MI, OH and countries of: Germany, Turkey, and AU.
Affected count
2,794 units
Manufactured in
1003 Calle Sombra, San Clemente, CA, United States
Products
Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065CE WGM35090US WGM35090CE WGM35135US WGM35135CE

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1898-2017

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